Tag Archive: bioequivalence

Jan 30

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Jun 10

Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” which became …

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May 18

FDA Enforcement of New IND and BA/BE Safety Reporting Requirements

FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011.  FDA’s intent for the final rule was to improve monitoring of adverse events (including those from BA/BE …

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Jul 09

June 2010 FDA Guidances

Image via Wikipedia Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in June 2010 (links go directly to PDF documents). Special Interest Guidances/Information Date Posted CMC Postapproval Manufacturing Changes Reportable in Annual Reports (Draft) 6/24/2010 Frequently …

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Jul 07

505(b)(2) Marketing Applications – Bridging the Gaps

There is no doubt that the drug development business is very expensive and development can take many years before a viable, money-generating product can be marketed. A strategy some of our clients implement to more quickly and more inexpensively develop a novel therapeutic product is to develop a drug that can rely on studies from …

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